Let's get a couple things out here where easier to see:
Fact: Average time from NDA approval to final DEA schedule is 200 days..... Lyrica was done at 210 days, while Lusedra was completed at 328 days..... Belviq is right in there now at about 250 days.
The DEA recommended schedule went out for comments, comment period closed, and now the DEA has to address comments and publish the schedule in FR..... once this happens there may be (unless waived per Eisai request) another 30 wait period until the final schedule is released.... but at that point the class is made public so the news is already out and preparations for launch underway (at that point this is not likely to be a factor since some time is required to get launch ready anyway).
Let's see what happens in the next couple weeks...... will be interesting.... and ready to watch the next big naked shorting battle required to reign in the stock price again..... SEC are you watching???
DEA has agreed with the FDA on schedule FOUR....Public comments will not change that scheduling at all..At adcom they recommended lorc for approval and fda granted it and rec a schedule 4, the only thing that is delaying Belviq from launch is that dea must answer the public comments and there was alot of them, most not even worth an answer...VVUS shareholders and arna shorties are gaming the system , its worked well for them , so well that I bet they look back and say we should of done 500 more..This process is useless
So then the only thing for shorts to hang their hope on is EU approval and sales? I agree dog, and think they are far underestimating how patients will FIRST want to try the most mild tolerable drug possible before going to others. Mild tolerable help with food cravings that IS COMPATIBLE with an effective diet and exercise program..... encourages healthy lifestyle changes.
In addition, Q can not, did not, and never will touch the T2DM results proven in Bloom-DM..... if short siders are banking on diet pill sales alone, then they are underestimating grossly. Going to be fun.
Good post and comments. People should not attack the DEA alleging corruption. It is part of the Dept. of Justice and the last place you should be looking for fraud and corruption. It is even possible that they have a negative view of the shorters and manipulators and plan to get them when it hurts - when options expire.
In addition to all the issues brought up in the letters to the DEA that may have slowed things down, we must also consider their weighing of the immediate marketing request. This extra time is longer than any I've seen without a hearing request. Thus, if they were not before, the delay may make them more sympathetic to the waiver request so marketing can immediately begin. Although I hope the DEA announces tomorrow to destroy the shorts and because everyone is going batty waiting (and some have been hurt badly), it is good for me since it allowed me amass more shares this week. I bought more at the bell today and plan to buy more tomorrow if it does not gap up. Its hard not to buy at this price.
Sentiment: Strong Buy
If the DEA class is anything other than the recommended Class IV it will be because of outsider's influence.... The DEA draft called for Class IV leading into the comment stage... for them to change this status would indicate corrupt meddling from the outside, and the next question is "what are the interests of anyone seeking to alter the DEA decision process"... followed shortly by which law firm will be first to file legal action and demand full discovery and disclosure.
There's another point to make about the attack comments on the FR page. And I wonder just how many of you actually bothered to read them? I did. I don't know if they are still there, but some of you who want to believe they are trivial need to think again. Some of them are quite well crafted to trigger specific concerns at DEA. They are not scientifically valid enough (in my view) to change the classification, but they are certainly "cunning" enough to make a non-scientist at DEA want to have a full scientific opinion from NIDA (the NIH agency the DEA sub-contracts to review the science). For example, there are several comments that suggest combining Belviq with other drugs (notable P ter mine) could create specific problems that concern the DEA, and those comments include statements from ARNA that such combinations are planned. I do not know if the original DEA review considered combinations, or whether it was even supposed to. But to a non-scientist bureaucrat at DEA, that kind of comment certainly could trigger some concerns, and hence cause the files to be sent back to NIDA. I will say again - to dismiss the attack comments as all being trivial is wishful thinking, as some of them are substantive enough to need a proper review. Look at it from the DEA perspective, not ARNAs. I will also say again that almost all of these attack comments, except for the Mannsbach letter, came after AF's taunting article about the ARENiacs spamming the FR. Go figure...
I also read the full report a couple of weeks ago and the comment that stuck in my mind was that a determination would be made in a "reasonable length of time", thus any comparable timelines have become a mute point. Your post and assumption are correct. We are simply is a wait and see mode.
dea can not stop combos ....phen/top are approved drugs and docs can combine them if they wish, dea has no control over docs in this regard or people who wish to do it on their own....this process is taking way to long and to blame it on the comments is just plain foolish imo...Would any of the comments have the dea change from schedule 4 to 3? NO, would they go against the fda and make a change because of a comment made on a public forum, NO...DEA cannot control ALL abusive behavior by people...Docs are responsible for their pts not the DEA....
RandG, mkann.... you make some good points in regards to what is involved in the scientific aspects of DEA review and at least as important, the convoluted process, which the industry and agencies are aware is not efficient and does not line up with FDA approval very well.... where I disagree most is the leap to accuse the agency (made of many people, not just one) of corruption..... this is just fear and complaining, imo.
no_ads_4_ thestreet.... great point about why can't the DEA issue a provisional class, even if it was started at a tighter level (like provisional at III with review to move toward IV or V).
To all.... the FDLI website has archives of their past conferences.... check out the session at the 2011 annual conference on DEA classification process..... it explains very well all the steps and problems..... it also clearly shows that the industry and agencies are well aware that the current mechanism can cost the sponsors IP value because the clock on IP often starts at FDA approval, not DEA class.... of course, it also costs patients valuable time by withholding access to treatment that could be important or even critical.
I think looking at the overall average time is not as useful as looking at the average time for the completion of this final stage. The average time between the end of the public comment period and the publication of final rule is about 40-45 days. The public comment period for Belviq ended 55 days ago, on January 18. So, the final rule could appear any day.
There is nothing in the Federal Register today (it is published at 3 am). In any event, the final rule will show up on the DEA's website around 9 am of the business day preceding the day it is published in the Federal Register. I am checking both every day, but it is still too early in the day to check the DEA website.
Of course the SEC is not watching unless you report them. Any volunteers? I've written to the SEC a gzillion times and right now don't have the time to do it again but if I did I would. Anybody has time on their hands to make a report ? I can send you their emails or just go to the complaints website. On that note, I get a lot of hits on my site with people googing adam f. sec investigation.
RG.... I've written them before.... if they aren't all over this by now, then there's a big problem. As to the DEA, I don't think further public advocacy is going to help at this point.... having said that, I saw one of your comments and did not think it was overly dramatic, enflamatory, or accusatory.
IMO.... Let it be..... for now
BTW.... the comments included several that were links to a document..... presumably a larger set of questions, comments, or issues..... so, we really have no idea how extensive or what the level of complexity really was.... we do know that some came from (undisclosed) short interests..... if you are seeking evidence of meddling (at best) or corruption (at worst), that might be a better starting point (just a thought, nothing specific or substantial).
people need to understand that this process is complicated.... it is not trivial like taking a drivers license test or stamping a passport. The technical details are complex and although there are problems that affect both the drug IP life cycle and the ability to get beneficial drugs to meet patient needs, the problems and solutions are also complicated.
If you want to read more on the process and issues involved check out the DEA website and the FDLI (Food and Drug Law Institute).... there is a wealth of information out there if you are willing to look and read. On of the topics coming to forefront is how to better deal with social media and advocacy input in the approval and scheduling process.... it can be a benefit and an impedance.
The DEA is not there to serve anyone investment thesis..... LONG or SHORT..... and I'd expect that this will at some point require new rules to help make review more efficient and new laws to deal with DISCLOSURE, CONFLICT OF INTEREST, and MEDDLING.... but that's just my humble opinion.
we understand that the process is not trivial but it is taking too much time with seemingly no deadline and without any transparency on the progress or lack of it . it is not as if dea is doing this for the first time. i am sure that they had some understanding about belviq when they initially accepted fda's class IV recommendation.
ventilating valid concerns is not impeding or MEDDLING.
Hi Dio: I don't think a lot of effort will be made to make the review more efficient. If they were doing 20 or so per year, then I would agree with you, but at 1.1 per year since 2000, why waste the time and effort. No Arena long imo is going not care much what happens to the DEA process once the final rule is filed in the FR.
Sentiment: Strong Buy
As in a previous posting you may note that many of us are Ph.D.'s who do conduct research. In my case for 15 years now. I don't think people are thinking that this is trivial. For example, my 400+ dissertation was blown apart by my committee with hundreds of corrections/clarifications/justifications needed.....within a month. The reason for stating this is that with 60+ comments it should not be taking this long whatsoever. I may be wrong here but I don't think you have been on the MB for months on end really reading the posts. A lot of people on here do understand research, do understand science, and do understand legitimate concerns. What people don't understand, but for a handful who think they do, is the length of time this is taking, the unresponsiveness of anyone from ARNA, and the lack of any transparency of the "process". Since there is no transparency this equates to no accountability on the tax paying publics part. As for the arguments that there are potential political connections between the DEA and Wall Street, I would say they are very plausible. As we have turned into a banana republic with corruption at all levels I am not sure why a connection between the DEA and Wall Street money would not exist. The problem is proving otherwise. As you said, the DEA is not there to serve investors. I wholeheartedly agree.....they are there to efficiently and effectively utilize the taxpayers money in the best interest of the public. This, in my opinion, is not occurring. I have been long and one of the most upsetting parts is that this dead money equates to opportunistic costs. I usually invest in the travel/tourism industry and the money I could have made, that I unfortunately sunk into ARNA, was exponential. I know it was my choice but it was also my choice assuming the rules of the game were fair, of which they are not. The odds are squarely against the retail investor. I rarely rant on here but it has been a day my frustration runneth over
Can understand that the process isn't a one week job, however the DOJ/DEA can certainly improve efficiency. I'm mystified that a temporary scheduling order isn't in place once the FDA approves a medicine. This would of course help patients in immediate need and would be especially helpful for medical conditions with few options on the market. Temporary scheduling orders are not unheard of; one was put forth for bath salts last October. Private companies need revenue to stay afloat so this delay has real repercussions for both the patients and the company...fortunately Arena had their ducks in order otherwise this could have been very ugly.
Sentiment: Strong Buy
I'm sorry, but I don't buy it. Most of us with any sort of scientific background could finish this in one week, if we put our mind to it. The DEA had six months to simply confirm the FDA's recommendation for schedule IV. They should have some sort of conviction prior to the comment period. Do you really think that there is some nuances that were presented in the comments that weren't already addressed by the FDA or the six months prior . It's not as if this is a highly addictive drug; only a schedule IV for god's sake. I realize that the DEA swims in pool of red tape, but this should be an easy decision since B has no addictive potential. Instead, it will be used to treat addictions: smoking, gambling! It just begs the question that there is something more nefarious at play here.